FDA approves Corlanor (ivabradine) to treat heart failure-Amgen

Amgen announced that the FDA has granted approval of Corlanor (ivabradine), an oral medication indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) less or equal to 35 percent, who are in sinus rhythm with resting heart rate greater than or equal to 70 beats per minute (bpm) and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.

Comment: Amgen obtained commercial rights in the U.S. to Servier's novel oral drug, approved in the EU as Procoralan (ivabradine), for chronic heart failure and stable angina in patients with elevated heart rates. Corlanor has a unique mechanism of action and it will complement the use of standard heart failure therapies, including beta blockers. Many people with chronic heart failure continue to suffer hospitalizations due to worsening heart failure despite beta blockade and other therapies. For these patients, when heart rate is greater than or equal to 70 bpm, Corlanor may be an appropriate treatment option and can be expected to add benefit.